Personalized Treatment Selection for Metastatic Breast Cancer

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Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

(Turnstile One - Applies only to inclusion criteria 1 - 4): Histologically confirmed breast cancer and evidence of metastatic disease that can be biopsied with acceptable risk. Patients must agree to mandatory fine needle aspiration of the cancer for response marker determination. Patient must have a positive gene expression profile. Positive gene expression signature obtained separately on trial LAB11-0337 will also be acceptable for eligibility.

Patients must have measurable or evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Subject, age > 18 years (the safety and efficacy of dasatinib and the appropriate dose has not been established for children).

Signed written informed consent including a HIPAA form according to institutional guidelines.

(Turnstile Two Applies Only to Inclusion Criteria 5 -17) - Therapy with Dasatinib - Patient must have a positive gene expression profile. Positive gene expression obtained separately on trial LAB11-0337 will also be acceptable for eligibility.

Full physical examination and history including documentation of weight, height, and vital signs within 8 days of starting therapy.

Patients may have received any number of previous therapies for metastatic breast cancer. Patients must have received, had a contraindication to, or declined treatment with an anthracycline and taxane (and Herceptin if HER-2 positive) in either the adjuvant or metastatic setting.

A baseline EKG within 14 days of starting therapy, with a QTc interval not > 460 msec in women, or > 450 in men.

Ability to take oral medication (dasatinib must be swallowed whole).

Patient must agree to discontinue St. Johns Wort while receiving dasatinib therapy if previously taken.

Patient must agree that IV bisphosphonate therapy will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia. (After the need for Ca2+ supplementation has been assessed and levels documented to be >LLN, subjects on prior bisphosphonate may be restarted with caution at the investigator's discretion).

Females of childbearing potential must have a negative serum pregnancy test within 7 days of starting therapy.

Persons of reproductive potential must agree to use and utilize a barrier method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.

Concurrent medications must be assessed, and patient must agree to discontinue all restricted medications within 7 days of starting therapy.

Concurrent medical condition which may increase the risk of toxicity, including: (a) pleural or pericardial effusion of any grade; (b) uncontrolled angina, congestive heart failure or MI within (6 months); (c) history of congenital long QT syndrome or prolonged QTc interval on pre-entry electrocardiogram > 460 msec in women and >450 msec. in men; (d) any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); continued in excl # 3

Women who are unwilling or unable to use a barrier method of contraception to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breast-feeding. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.

Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.